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Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

NCT00393458•Novartis

View on ClinicalTrials.gov

Summary

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
•1. Smoking history of at least 20 pack years
•2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
•3. Post-bronchodilator FEV1/FVC (forced volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

Exclusion Criteria

•Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
•Patients who had a respiratory tract infection within 6 weeks prior to screening.
•Patients with concomitant pulmonary disease.
•Patients with a history of asthma.
•Patients with diabetes type I or uncontrolled diabetes type II.
•Any patient with lung cancer or a history of lung cancer.
•Patients with a history of certain cardiovascular co-morbid conditions.

Locations (183)

Novartis Investigator Site

Buenos Aires, Argentina

Novartis

Buenos Aires, Argentina

Novartis Investigator Site

Mendoza, Argentina

Novartis Investigator Site

San Miguel, Argentina

Novartis Investigator Site

Santa Fe, Argentina

Novartis Investigator Site

Rancagua, Chile

Novartis

Santiago, Chile

Novartis Investigator Site

Viña del Mar, Chile

Novartis Investigator Site

Barranquilla, Colombia

Novartis

Bogotá, Colombia

Key Dates

Start Date

October 1, 2006

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

August 18, 2011

Enrollment

1,732

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol

DRUG

Formoterol

DRUG

Placebo to indacaterol

DRUG

Placebo to formoterol

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 18, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

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